Feedback from FDA following Type B meeting encourages clinical development of rupitasertib in advanced breast cancer
Scott Filosi, CEO of Evexta Bio, said: “The feedback we have received from the FDA on the clinical development plan for rupitasertib, along with the new preclinical efficacy data generated in estrogen-resistant breast cancer models, is enabling us to move forward with strong confidence to initiate our Phase 2 study. Advanced breast cancer patients with ESR1 mutations who progressed on or after a CDK4/6 inhibitor have limited treatment options, and our goal is to provide them with an effective and well-tolerated therapy choice.”
Share:
More News
“We are encouraged by the progress of our clinical trial and remain focused on our goal to develop innovative therapies that can address glioblastoma and other cancers. Although we are unable to provide detailed information at this stage, we are excited about the continued advancement of this important program,” said
“We are disappointed in the outcome of the RELATIVITY-098 trial and that LAG-3 inhibition in the adjuvant setting did not lead to the same improved efficacy outcomes seen in advanced melanoma,” said Jeffrey Walch, M.D., Ph.D., vice president, Opdualag global program lead, Bristol Myers Squibb. “Patients whose tumors are completely
Ahsan Arozullah, M.D., M.P.H., Senior Vice President, Head of Oncology Development, Astellas said, “The combination of enfortumab vedotin and pembrolizumab was the first approval to offer an alternative to platinum-containing chemotherapy, which had been the standard of care for first-line locally advanced or metastatic urothelial cancer for decades. We are
“U.S. FDA has accepted for review the resubmission of the BLA for linvoseltamab for the treatment of adult patients with relapsed/refractory (R/R) multiple myeloma (MM) who have received at least four prior lines of therapy or those who received three prior lines of therapy and are refractory to the last
